Colorectal PolypsNCT06927258
Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps
A study testing changyanning granules in people with Colorectal Polyps, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of Chanyanning granules in patients undergoing endoscopic resection of colorectal polyps with a basal diameter of 5-30 mm. From one day before the procedure to five days postoperatively, patients will be administered Chanyanning granules. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- changyanning granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with colorectal polyps through endoscopic examination and who received corresponding endoscopic treatments (EMR, hybrid ESD, ESD).
Who cannot join
- Concurrent infectious diseases or malignant tumors; Accompanied by severe cardiopulmonary diseases (such as severe heart failure, COPD, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
About this study
This study aims to evaluate the efficacy of Chanyanning granules in patients undergoing endoscopic resection of colorectal polyps with a basal diameter of 5-30 mm. From one day before the procedure to five days postoperatively, patients will be administered Chanyanning granules. The study will observe intraoperative and postoperative bleeding, perforation, and digestive system-related clinical symptoms such as postoperative abdominal pain, bloating, diarrhea, constipation, hematochezia, and fatigue, as well as related inflammatory markers, to determine the therapeutic effect of Chanyanning granules.
- Conditions
- Colorectal Polyps
- Being tested
- changyanning granules, Placebo
- Keywords
- colorectal polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
changyanning granulesDrug
Also called control
From one day before the procedure to five days postoperatively, patients in the experimental group will be administered Chanyanning granules.
PlaceboDrug
control
| Study group | Role | What they receive |
|---|---|---|
| The Changyanning group | Active comparator | The Changyanning group takes Changyanning granules starting from 1 day before surgery until 5 days after surgery. The granules are taken preoperatively at the same time as the first dose of laxative, and postoperatively starting after resuming an open diet. Receives: Drug: changyanning granules |
| The control group | Placebo comparator | The control group does not use Changyanning granules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum interleukin-6
Measured: From enrollment to the end of treatment at 2 weeks
The incidence of complications
The incidence of complications (blood in stool, perforation) and postoperative discomfort symptoms (abdominal pain, abdominal distension, diarrhea, constipation, fatigue, fever, etc.) were compared between the experimental group and the control group (primary endpoints).
Measured: From enrollment to the end of treatment at 2 weeks
white blood cells
Measured: From enrollment to the end of treatment at 2 weeks
C-reactive protein
Measured: From enrollment to the end of treatment at 2 weeks
erythrocyte sedimentation rate
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (2)
hospital stay
Measured: From enrollment to the end of treatment at 2 weeks
hospitalization costs
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start1 Nov 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927258
- Sponsor's protocol ID
- 2024-0661
- Status last verified
- Aug 2024
- First submitted
- 18 Oct 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps
- ClinicalTrials.gov ID
- NCT06927258
- Acronym / sponsor ID
- 2024-0661
- Conditions
- Colorectal Polyps
- Keywords
- colorectal polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy of Chanyanning granules in patients undergoing endoscopic resection of colorectal polyps with a basal diameter of 5-30 mm. From one day before the procedure to five days postoperatively, patients will be administered Chanyanning granules. The study will observe intraoperative and postoperative bleeding, perforation, and digestive system-related clinical symptoms such as postoperative abdominal pain, bloating, diarrhea, constipation, hematochezia, and fatigue, as well as related inflammatory markers, to determine the therapeutic effect of Chanyanning granules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Changyanning group | Active comparator | Drug: changyanning granulesThe Changyanning group takes Changyanning granules starting from 1 day before surgery until 5 days after surgery. The granules are taken preoperatively at the same time as the first dose of laxative, and postoperatively starting after resuming an open diet. |
| The control group | Placebo comparator | Drug: PlaceboThe control group does not use Changyanning granules. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with colorectal polyps through endoscopic examination and who received corresponding endoscopic treatments (EMR, hybrid ESD, ESD).
Key exclusion criteria (1 listed)
- Concurrent infectious diseases or malignant tumors; Accompanied by severe cardiopulmonary diseases (such as severe heart failure, COPD, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| changyanning granulesAlso: controlFrom one day before the procedure to five days postoperatively, patients in the experimental group will be administered Chanyanning granules. | Drug | The Changyanning group |
| Placebocontrol | Drug | The control group |
Primary outcome
serum interleukin-6
Time frame: From enrollment to the end of treatment at 2 weeks
The incidence of complications
Time frame: From enrollment to the end of treatment at 2 weeks
The incidence of complications (blood in stool, perforation) and postoperative discomfort symptoms (abdominal pain, abdominal distension, diarrhea, constipation, fatigue, fever, etc.) were compared between the experimental group and the control group (primary endpoints).
white blood cells
Time frame: From enrollment to the end of treatment at 2 weeks
C-reactive protein
Time frame: From enrollment to the end of treatment at 2 weeks
erythrocyte sedimentation rate
Time frame: From enrollment to the end of treatment at 2 weeks
2 secondary outcomes
hospital stay
Time frame: From enrollment to the end of treatment at 2 weeks
hospitalization costs
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing changyanning granules in people with Colorectal Polyps, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum interleukin-6 (time frame: From enrollment to the end of treatment at 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.